Alimera Sciences Resubmits Iluvien NDA To FDA
By Cyndi Root
Alimera Sciences announced in a press release that it resubmitted its Iluvien application to the Food and Drug Administration (FDA). The resubmission was filed in response to the Complete Response Letter (CRL) sent to the company by the FDA in October of 2013. Iluvien is a medication for Diabetic Macular Edema. Alimera licenses the eye drug from pSvidia. Dan Myers, Alimera's president and CEO said, "We are pleased to resubmit ILUVIEN for approval in the United States. We look forward to an acknowledgment from the FDA that the response is complete and that a PDUFA date has been confirmed."
Diabetic Macular Edema
Diabetic macular edema (DME) can occur in patients with diabetic retinopathy, damage to the blood vessels in the retina. When blood or plasma constituents leak into the macula, responsible for forward vision, the macula swells and distorts vision. Diabetes patients have a 10 percent risk of developing DME and blindness. About 300,000 people in the U.S. develop DME each year. Patients with type 1 or 2 diabetes are equally at risk and should have a yearly eye exam. DME is treated with laser surgery and drugs such as Lucentis, Avastin, or Aylea.
Iluvien
Iluvien (fluocinolone acetonide) is a drug implant. It delivers micrograms of the therapeutic agent during its sustained release action for up to 36 months. 190 µg of fluocinolone acetonide (FAc), a corticosteroid, is contained in the ultra small cylinder. The drug comes packaged in an applicator and the physician injects the intravitreal implant into the back of the eye, and the wound seals itself.
FDA Approval Process
The FDA has rejected Ilvien three times. The most recent rejection included a requirement for a new clinical trial and review by an advisory panel. The FDA has dropped the requirements and instead has begun discussions on labeling. Some industry experts believe that the FDA changed its tune due to the success of Iluvien in other markets. The drug is approved in several European countries.
Iluvien Studies
Alimera conducted clinical studies in The U.S., Canada, and Europe. The study known as FAME (Fluocinolone Acetonide in Diabetic Macular Edema) enrolled 956 patients. Two doses were studied: .45 micrograms (µg) per day and 0.23 µg per day. Both doses are smaller than other DME experimental drugs undergoing trial. Study results are still under review. Adverse reactions reported include cataracts and increased ocular pressure.